A new point-of-care influenza test, and the first to deliver highly accurate molecular results in less than 15 minutes, was approved on June 13 by the US Food and Drug Administration, the manufacturer, Alere, announced today.
The quick turnaround of the Alere i Influenza A & B Test allows a clinician to diagnose what ails a patient during an office visit and immediately begin the correct course of treatment, according to Alere.
There are already rapid influenza detection tests (RIDTs) on the market that produce results in 15 minutes or so, but these rely on enzyme immunoassay technology, which spots antigens to the seasonal influenza virus in clinical specimens. Such RIDTs have sensitivity rates ranging from 50% to 70%, resulting in high rates of false negatives, according to the Centers for Disease Control and Prevention. Alere said that the sensitivity of its new flu test tops 90% for both influenza A and B. Like some RIDTs, the Alere i Influenza A & B Test can distinguish between the 2 varieties.
The new test extracts and analyzes DNA and RNA strands to detect sequences associated with viral and bacterial infections, Alere said. In terms of accuracy, the results resemble those possible with slower polymerase chain reaction tests, which can take 1 to 6 hours.
More information on today's announcement is available on the Alere Web site.
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Cite this: New Flu Test Delivers Molecular Results in Under 15 Minutes - Medscape - Jun 16, 2014.